Stefano R. Carchedi; Marie L. Foegh Ramwell; and James G. Cullem

U.S. SECURITIES AND EXCHANGE COMMISSION

Litigation Release No. 26265 / March 12, 2025

Securities and Exchange Commission v. Stefano R. Carchedi, Marie L. Foegh Ramwell, and James G. Cullem, No. 1:25-cv-10599 (D. Mass. filed Mar. 12, 2025)

SEC Charges Three Former Biopharmaceutical Company Executives with Scheme to Mislead About Cancer Drug Application

The Securities and Exchange Commission today filed charges against Stefano R. Carchedi, Marie L. Foegh Ramwell, and James G. Cullem—the former chief executive officer, chief medical officer, and chief business officer of Massachusetts-based biopharmaceutical company Allarity Therapeutics, Inc., respectively—for scheming to conceal from investors a harsh critique levied by the Food and Drug Administration in February 2020 about the likelihood that dovitinib, Allarity’s flagship cancer drug candidate, would be approved by the FDA.

The SEC’s complaint alleges Carchedi, Foegh and Cullem learned in February 2020 that the FDA recommended against seeking approval for dovitinib because Allarity’s data was insufficient and instead recommended Allarity conduct a new Phase III clinical trial—something it had no intention of doing. According to the SEC’s complaint, rather than revealing the FDA’s negative feedback to investors, Carchedi, Foegh and Cullem misled investors by creating press releases that propagated false and misleading claims about dovitinib’s likelihood of FDA approval while Allarity raised money from investors to stay afloat. Carchedi also allegedly signed several documents filed with the SEC or posted on Allarity’s website that similarly misled investors about dovitinib’s prospects for FDA approval.

The SEC’s complaint, filed in the District Court for the District of Massachusetts, charges Carchedi with violating Section 17(a) of the Securities Act of 1933, Section 10(b) of the Securities Exchange Act of 1934 and Rule 10b-5 thereunder and charges Foegh and Cullem with violating Sections 17(a)(1) and (3) of the Securities Act, Section 10(b) of the Exchange Act and Rules 10b-5(a) and (c) thereunder. The SEC seeks permanent injunctions, disgorgement with prejudgment interest, civil monetary penalties, and officer and director bars against all defendants.

The SEC’s investigation is being handled by Dawn Edick, David Fox, Susan Cooke and Amy Gwiazda of the Boston Regional Office.